Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on improving
the intracellular delivery of critical therapeutics through its
paradigm-changing lipid nanocrystal (LNC) platform delivery
technology, today announced that it has dosed the first patient in
a Phase 1 single ascending dose (SAD) pharmacokinetic study in
healthy volunteers with MAT2501. The Company expects to complete
enrollment of the Phase 1 SAD study in the first quarter of 2022,
with data anticipated during the second quarter of 2022. Pending
successful completion of the Phase 1 SAD study, the Company expects
to start a Phase 2 program in patients with nontuberculous
mycobacterial (NTM) infections by the first quarter of 2023,
following required longer-term preclinical toxicology studies to be
conducted during 2022.
MAT2501 is being developed to potentially become
the first oral aminoglycoside, with the application of Matinas’
proprietary LNC platform technology to the broad-spectrum
antibiotic drug amikacin. Amikacin is a highly potent antibiotic
used to treat chronic and acute bacterial infections, including
problematic gram-negative infections. Currently, amikacin’s use (IV
or inhalation) is severely limited due to associated major side
effects including nephrotoxicity and ototoxicity (hearing loss and
potentially permanent impairment of balance), as well as inhalation
complications with certain approved therapies.
“Following the robust data from MAT2203 in the
EnACT trial announced in September 2021, MAT2501 now becomes our
second clinical stage product candidate demonstrating the benefits
of our LNC platform delivery technology in treating infectious
diseases. Our goal with MAT2501 is to develop the first oral
aminoglycoside, which could transform the use of this important
class of drugs,” stated Jerome D. Jabbour, Chief Executive Officer
of Matinas. “At its core, our LNC platform facilitates
intracellular delivery. We believe that MAT2501’s ability to
orally, effectively, efficiently and safely deliver therapeutic
levels of amikacin that specifically target the lung, without
use-limiting toxicity, clearly distinguishes it from other
available therapies for the treatment of NTM infections.
Furthermore, we believe that the ultimate applicability of MAT2501
will not be limited to the treatment of pulmonary infections, and
we expect to evaluate its use in other, more acute bacterial
infections, such as gram-negative infections, where the unmet
medical need is significant and unfortunately growing due to a lack
of effective therapies.”
This Phase 1 study is a double-blind,
placebo-controlled, SAD study designed primarily to evaluate the
safety, tolerability and pharmacokinetics of single ascending oral
doses of MAT2501 in healthy adult subjects. Secondary objectives
include the assessment of the effect of food on the
pharmacokinetics of amikacin following a single oral dose of
MAT2501.
Development of MAT2501 has been supported by a
$4.2 million Therapeutics Development Award from the Cystic
Fibrosis Foundation.
The U.S. Food and Drug Administration (FDA) has
designated MAT2501 as a Qualified Infectious Disease Product (QIDP)
and as an Orphan Drug for the treatment of NTM. If MAT2501 is
ultimately approved by the FDA, the seven-year period of marketing
exclusivity from orphan designation combined with the additional
five years of marketing exclusivity provided by the QIDP
designation, would provide for a potential total of 12 years of
marketing exclusivity.
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on improving the intracellular delivery of critical
therapeutics through its paradigm-changing lipid nanocrystal (LNC)
delivery platform. The Company is developing its own internal
portfolio of products as well as partnering with leading
pharmaceutical companies to develop new formulations that take full
advantage of the unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
complex challenges in achieving safe and effective intracellular
delivery, for both small molecules and larger, more complex
molecules, such as mRNA, DNA plasmids, antisense oligonucleotides
and vaccines. The combination of a unique mechanism of action and
flexibility in both the formulation and route of administration
(including oral), position Matinas’ LNC technology to potentially
become the preferred next-generation intracellular drug delivery
vehicle and an important improvement over both lipid nanoparticles
and viral vectors.
MAT2203 is an oral, LNC formulation of the
highly effective, but also highly toxic, antifungal medicine
amphotericin B, primarily used as a first-line treatment for
invasive fungal infections. MAT2203 is currently in a Phase 2
open-label, sequential cohort study (EnACT) in HIV-infected
patients with cryptococcal meningitis. Enrollment in Cohort 3 of
EnACT has commenced following unanimous approval from the Data and
Safety Monitoring Board (DSMB), with enrollment completion and DSMB
evaluation of Cohort 3 data expected in the fourth quarter of
2021.
MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside antibiotic amikacin, primarily used
to treat chronic and acute bacterial infections. With the support
of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing
important preclinical studies and commenced a Phase 1 human
clinical trial in the fourth quarter of 2021. MAT2501 would be the
first and only oral aminoglycoside and is being positioned with an
initial indication for the treatment of nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis.
LYPDISO™, is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA,
intended for the treatment of cardiovascular and metabolic
conditions. This next-generation omega-3 therapy has been shown in
two head-to-head studies to provide effective triglyceride-lowering
and significantly higher EPA blood levels than Vascepa®. The
Company has initiated a process to identity and potentially secure
a partner to continue development of LYPDISO.
Forward Looking Statements
This release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including those relating to our business
activities, our strategy and plans, the potential of our LNC
platform delivery technology, and the future development of its
product candidates, including MAT2203, MAT2501, the anticipated
timing of regulatory submissions, the anticipated timing of
clinical studies, the anticipated timing of regulatory
interactions, the Company’s ability to identify and pursue
development and partnership opportunities for its products or
platform delivery technology on favorable terms, if at all, and the
ability to obtain required regulatory approval and other statements
that are predictive in nature, that depend upon or refer to future
events or conditions. All statements other than statements of
historical fact are statements that could be forward-looking
statements. Forward-looking statements include words such as
"expects," "anticipates," "intends," "plans," "could," "believes,"
"estimates" and similar expressions. These statements involve known
and unknown risks, uncertainties and other factors which may cause
actual results to be materially different from any future results
expressed or implied by the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to obtain
additional capital to meet our liquidity needs on acceptable terms,
or at all, including the additional capital which will be necessary
to complete the clinical trials of our product candidates; our
ability to successfully complete research and further development
and commercialization of our product candidates; the uncertainties
inherent in clinical testing; the timing, cost and uncertainty of
obtaining regulatory approvals; our ability to protect the
Company’s intellectual property; the loss of any executive officers
or key personnel or consultants; competition; changes in the
regulatory landscape or the imposition of regulations that affect
the Company’s products; and the other factors listed under "Risk
Factors" in our filings with the SEC, including Forms 10-K, 10-Q
and 8-K. Investors are cautioned not to place undue reliance on
such forward-looking statements, which speak only as of the date of
this release. Except as may be required by law, the Company does
not undertake any obligation to release publicly any revisions to
such forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events. Matinas BioPharma’s product candidates are all in a
development stage and are not available for sale or use.
Investor and Media Contacts
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
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